Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes (Cinétique DAPA)
Primary Purpose
Type-2 Diabetes, Oral Antidiabetics
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Dapagliflozin
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Type-2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- persons who have provided written consent
- type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
- Stable treatment for 3 months
- HbA1c between 7.5% and 10%
- Age between 30 and 65 years
- BMI between 25 and 35 kg/m²
- Triglycerides < 300 mg/dl
- Half of the patients being treated with statins
- eGFR > 75 ml/min/1.73 m² at inclusion
Exclusion Criteria:
- persons without national health insurance cover
- patients treated with Insulin or a GLP-1 agonist
- Patients under guardianship
- patients treated with lipid-lowering drugs (except statins for 50% of patients)
- kidney failure
- liver failure or abnormal liver function ASAT or ALAT >3 x upper limit of normal
- total bilirubin >2mg/dl
- intestinal disease
- serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
- Pregnancy, breastfeeding
- hypersensitivity to the active substance or to excipients
- patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
- patients treated with loop diuretics or thiazides
Sites / Locations
- CHU Dijon BourgogneRecruiting
- CHU de NantesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients not treated with statins
Patients treated with statins
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline the rate of production of VLDL Apo B
Change from baseline the rate of production of IDL Apo B
Change from baseline the rate of production of LDL Apo B
Change from baseline the rate of production of HDL Apo A1
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
Change from baseline the Fractional Catabolic Rate of IDL Apo B
Change from baseline the Fractional Catabolic Rate of LDL Apo B
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
Secondary Outcome Measures
Full Information
NCT ID
NCT03269058
First Posted
August 25, 2017
Last Updated
November 19, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03269058
Brief Title
Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes
Acronym
Cinétique DAPA
Official Title
Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.
The information will:
reveal what is not working properly
make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning
This biomedical research will take place at the University Hospitals of DIJON and NANTES.
28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
Participation in the study will last 6 months and include 4 protocol visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-2 Diabetes, Oral Antidiabetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients not treated with statins
Arm Type
Experimental
Arm Title
Patients treated with statins
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin 10 mg daily per os
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo of Dapagliflozin per day per os
Primary Outcome Measure Information:
Title
Change from baseline the rate of production of VLDL Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the rate of production of IDL Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the rate of production of LDL Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the rate of production of HDL Apo A1
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the Fractional Catabolic Rate of IDL Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the Fractional Catabolic Rate of LDL Apo B
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
Title
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
Time Frame
15 days before treatment initiation, Day 0, Day 90 and Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
persons who have provided written consent
type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
Stable treatment for 3 months
HbA1c between 7.5% and 10%
Age between 30 and 65 years
BMI between 25 and 35 kg/m²
Triglycerides < 300 mg/dl
Half of the patients being treated with statins
eGFR > 75 ml/min/1.73 m² at inclusion
Exclusion Criteria:
persons without national health insurance cover
patients treated with Insulin or a GLP-1 agonist
Patients under guardianship
patients treated with lipid-lowering drugs (except statins for 50% of patients)
kidney failure
liver failure or abnormal liver function ASAT or ALAT >3 x upper limit of normal
total bilirubin >2mg/dl
intestinal disease
serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
Pregnancy, breastfeeding
hypersensitivity to the active substance or to excipients
patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
patients treated with loop diuretics or thiazides
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno VERGES
Phone
03.80.29.38.54
Ext
+33
Email
bruno.verges@chu-dijon.fr
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno VERGES, MD
Phone
03 80 29 38 54
Ext
+33
Email
bruno.verges@chu-dijon.fr
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel KREMPF, MD
Phone
02 53 48 27 07
Ext
+33
Email
michel.krempf@univ-nantes.fr
12. IPD Sharing Statement
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Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes
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